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LCP Proximal Tibial Plate 3.5. Part of the Synthes Small Fragment LCP System.

Surgical Technique

This publication is not intended for distribution in the USA.

Instruments and implants approved by the AO Foundation.

Image intensifier control

This description alone does not provide sufficient background for direct use of DePuy Synthes products. Instruction by a surgeon experienced in handling these products is highly recommended.

Processing, Reprocessing, Care and MaintenanceFor general guidelines, function control and dismantling of multi-part instruments, as well as processing guidelines for implants, please contact your local sales representative or refer to:http://emea.depuysynthes.com/hcp/reprocessing-care-maintenanceFor general information about reprocessing, care and maintenance of Synthes reusable devices, instrument trays and cases, as well as processing of Synthes non-sterile implants, please consult the Important Information leaflet (SE_023827) or refer to: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance

LCP Proximal Tibial Plate 3.5 Surgical Technique DePuy Synthes 1

Introduction

Surgical Technique

Product Information

MRI Information 19

Table of Contents

LCP Proximal Tibial Plate 3.5 2

AO Principles 4

Indications and Contraindications 5

Implantation 6

Cleaning of Instruments 14

Implants 15

Sets 17

2 DePuy Synthes LCP Proximal Tibial Plate 3.5 Surgical Technique

The LCP Proximal Tibial Plate 3.5 is part of the Small Frag-ment LCP System, which merges locking screw technology with conventional plating techniques.

The LCP Proximal Tibial Plate 3.5 has a limited-contact pro-file. The head and neck portions of the plate accept 3.5 mm Stardrive or hexagonal locking screws. The screw hole pat-tern allows a raft of subchondral locking screws to buttress and maintain reduction of the articular surface. This provides resistance to local depression loads in addition to the stabil-ity of the fixed-angle construct created by locking the screws into the plate.

The Locking Compression Plate (LCP) has combi-holes in the plate shaft which combine a dynamic compression unit (DCU) hole with a locking screw hole. The combi-hole pro-vides flexibility of axial compression and locking capability throughout the length of the plate shaft.

LCP Proximal Tibial Plate 3.5. Part of the Synthes Small Fragment LCP System.


Combi-holes combine a DCU hole with a threaded locking hole

Three 2.0 mm holes for Kirschner wires and sutures

Undercuts added to Kirschner wire holes to allow for suture needle passing

Accepts Articulated Tension Device (to provide compression or distraction)

Proximal bend “lower” than standard plate

Elongated combi hole to aid in plate placement

Angled locking holes to support medial fragments

Four locking screw holesStandard bend plate

Low bend plate

Plate shaft – Available with 4, 6, 8, 10, 12, 14, or 16 screw holes. – The three locking holes distal to the plate head accept

Locking Screw B 3.5 mm (Stardrive or hexagonal) or Cortex Screw B 3.5 mm or Shaft Screw B 3.5 mm to secure plate position. The hole angles allow the locking screws to converge with three of the four locking screws in the plate head to support medial fragments.

– Combi-holes, distal to the three angled locking holes, combine a DCU hole with a threaded locking hole. The combi-holes accept Locking Screw B 3.5 mm (Stardrive or hexagonal) or Cortex Screw B 3.5 mm or Shaft Screw B 3.5 mm in the threaded portion of the hole and Locking Screw B 3.5 mm (Stardrive or hexagonal) or Cortex Screw B 3.5 mm or Shaft Screw B 3.5 mm in the DCU portion of the hole.

Available in left and right plates, in implant quality 316L stainless steel or pure Titanium (TiCP).

Plate head – Anatomically contoured to match the lateral proximal

tibia. – Four convergent threaded screw holes accept:

– Locking Screw B 3.5 mm (Stardrive or hexagonal) – Cortex Screw B 3.5 mm – Shaft Screw B 3.5 mm

– Three 2.0 mm holes for preliminary fi xation with Kirschner wires, or meniscal repair with sutures.

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4 DePuy Synthes Expert Lateral Femoral Nail Surgical Technique

AO PRINCIPLES

In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation1, 2.

1 Müller ME, M Allgöwer, R Schneider, H Willenegger. Manual of Internal Fixation. 3rd ed. Berlin Heidelberg New York: Springer. 1991.

2 Rüedi TP, RE Buckley, CG Moran. AO Principles of Fracture Management. 2nd ed. Stuttgart, New York: Thieme. 2007.

Anatomic reductionFracture reduction and fixation to restore anatomical relationships.

Early, active mobilizationEarly and safe mobilization and rehabilitation of the injured part and the patient as a whole.

Stable fixationFracture fixation providing abso-lute or relative stability, as required by the patient, the injury, and the personality of the fracture.

Preservation of blood supplyPreservation of the blood supply to soft tissues and bone by gentle reduction techniques and careful handling.


AO Principles

1 Müller ME, Allgöwer M, Schneider R, Willenegger H. Manual of Internal Fixation. 3rd ed. Berlin, Heidelberg, New York: Springer. 1991.

2 Rüedi TP, Buckley RE, Moran CG. AO Principles of Fracture Management. 2nd ed. Stuttgart, New York: Thieme. 2007.

Stable fixationFracture fixation providing absolute or relative stability, as required by the patient, the injury, and the personality of the fracture.

Anatomic reductionFracture reduction and fixation to restore anatomical relationships.

Early, active mobilizationEarly and safe mobilization and rehabilitation of the injured part and the patient as a whole.

Preservation of blood supplyPreservation of the blood supply to soft tissues and bone by gentle reduction techniques and careful handling.

In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation1,2.


Indications – Split-type fractures of the lateral tibial plateau – Lateral split fractures with associated depressions – Pure central depression fractures – Split or depression fractures of the medial plateau

ContraindicationsIsolated shaft fractures.

Note: For associated shaft fractures is recommended to use a stronger plate such as the 4.5 mm LCP PTP or the 4.5 mm PLT/LISS plates for obese patients. In all cases an adapted reduced post-operative mobilization is manda tory.

For contraindications of Norian Drillable or chronOS Inject see the corresponding surgical techniques (Norian Drillable DSEM/BIO/0515/0032, chronOS Inject DSEM/BIO/1015/0040).

Indications and Contraindications


1Preparation

Complete the preoperative radiographic assessment and pre-pare the preoperative plan. Determine plate length and in-struments to be used. Determine proximal screw placement and screw lengths to ensure proper screw placement in the metaphysis.

Position the patient supine on a radiolucent operating table. Visualization of the proximal tibia under fluoroscopy in both the lateral and AP views is necessary.

Required setA Small Fragment LCP Instrument Set is required when im-planting the LCP Proximal Tibial Plate 3.5.

Recommended additional sets – Basic Instrument Set, for LC-DCP and DCP – Small Fragment Instrument and Implant Set–LC-DCP,

with self-tapping screws – Bone Forceps Set – Large Distractor Set – Large External Fixator Set with self-drilling Schanz screws – Periarticular Reduction Forceps Set – Pelvic Implant Set, with self-tapping screws (for longer

length 3.5 mm cortex screws up to 110 mm)

Note: More detailed information on conventional and locked plating principles can be found in the Synthes Locking Compression Plate (LCP) surgical technique (DSEM/TRM/0115/0278(1)).

Precautions: – Instruments and screws may have sharp edges or moving

joints that may pinch or tear user’s glove or skin. – Handle devices with care and dispose worn bone cutting

instruments in an approved sharps container.

Implantation

X-ray template for right LCP Proximal Tibial Plates 3.5 (Art. No. 034.000.492)

X-ray template for left LCP Proximal Tibial Plates 3.5 (Art. No. 034.000.495)


2Reduce articular surface

Note: Prior to reduction, application of an external fixator or Large Distractor (394.350) may facilitate visualization and reduction of the joint.

Reduce the fracture fragments and confirm reduction using image intensification. Fragments may be reduced using inde-pendent Kirschner wires; however, Kirschner wire holes are also provided on the plate to help achieve provisional reduc-tion, plate position, or fixation.

The locking screws do not provide interfragment or plate-to-bone compression; therefore, any desired compression must be achieved with traditional lag screws. The articular frag-ments must be reduced and compression must be obtained prior to applying the LCP Proximal Tibial Plate 3.5 with lock-ing screws.

Note: To verify that lag screws will not interfere with plate placement, hold the plate laterally to the bone.

3Determine proximal screw placement

Prior to placing the plate on the bone, thread two 2.8 mm Threaded Drill Guides (312.648) into two nonadjacent threaded holes in the plate head. Insert 2.8 mm Percutane-ous Drill Bits (324.214) through the guides and confirm that the drill bits are parallel in the transverse plane. This verifies that the guides are properly threaded into the plate, which ultimately ensures accurate screw placement.


4Determine plate position

Using anatomic landmarks and fluoroscopy, mount the plate on the intact or reconstructed plateau without attempting to reduce the distal portion of the fracture.

Insert a 2.0 mm Kirschner Wire (292.200) through a Kirschner wire hole. Readjust plate position, if necessary. Place a second Kirschner wire in a Kirschner wire hole to prevent rotation of the plate and to secure provisional fixa-tion of the plate to the tibial plateau. The Kirschner wires should penetrate and extend several milli meters beyond the medial cortex.

Note: An additional 2.0 mm Kirschner wire may be placed in the third Kirschner wire hole to hold the plate in position.

Prior to proceeding, confirm plate head placement. Use clini-cal examination and fluoroscopy to confirm that: – Screw trajectories in the proximal locking holes are paral-

lel to the joint in the transverse plane, and the plate is orientated properly on the plateau.

– Screw and plate placement are consistent with the pre-operative plan.

– Alignment of the plate to the shaft of the tibia is correct in both the AP and lateral views. Placement of the plate at this point will determine final flexion/extension reduction.

5Drill for proximal screws

While the plate is placed against the bone, use the 2.8 mm Percutaneous Drill Bit (324.214) to drill for the locking screw through one of the two threaded guides attached to the plate. It is imperative to drill using fluoroscopy to ensure proper screw trajectory and screw placement. Drill through to the medial cortex or the desired screw tip location.

Determine the appropriate screw length indicated on thecalibrated drill bit. Remove the drill bit and drill guide.

Alternatively, the Depth Gauge (319.090) can be used todetermine the appropriate screw length.

Implantation


6Insert proximal screws

Note: This plate can serve as a buttress for a medial wedge. This is accomplished by the convergence of the metaphyseal locking screws and the oblique locking screws from below.

If lag screw reduction of a fragment is required, this must be accomplished prior to inserting locking screws into the fragment. It may be necessary to predrill the lateral cortex using the 2.8 mm percutaneous drill bit.

Insert the appropriate length locking screw into the bone with power, using the 1.5 Nm Torque Limiting Attachment (TLA) (511.770 or 511.773) and Stardrive or Hexagonal Screwdriver Shaft (314.116 or 314.030).

Notes: – Always use the TLA (Torque Limiting Attachment) when

using power. – Locking screws are not lag screws. When interfragmen-

tary compression is desired, use conical screws B 3.5 mm or cortex screws B 3.5 mm.

At this point, verify screw placement using C-arm imaging.

AlternativeUse the Stardrive or Hexagonal Screwdriver (314.115 or 314.070) to manually insert the appropriate locking screw. Carefully tighten the locking screw, as excessive force is not necessary to produce effective screw-to-plate locking.

Repeat for remaining proximal locking holes. Securely tighten all locking screws to lock them to the plate.

1 2 2 1

2 1 1 2


Incorrect

Correct

7Reduce shaft to tibial plateau

Reduce the tibial plateau to the shaft of the tibia, using indi-rect reduction techniques whenever possible. Using atrau-matic technique, secure the plate to the tibial shaft with bone forceps.

Confirm rotational alignment of the extremity by clinicalexamination.

Once reduction is satisfactory, and if it is appropriate based on the fracture morphology, the plate should be loaded in tension using the Articulated Tension Device (321.120).*

Note: With multifragment fractures, it may not always be possible or desirable to achieve anatomic reduction of the fracture. However, in simple fracture patterns, the Articu-lated Tension Device may facilitate anatomic reduction. This device may be used to generate either compression or dis-traction.

In addition to having threaded locking holes, the plate func-tions similarly to DCP plates which offer the ability to self- compress fracture fragments. Therefore, a combination of lag screws and locking screws may be used.

Notes: – If a combination of cortex (1) and locking screws (2)

is used, a cortex screw should be inserted first to pull the plate to the bone.

– If locking screws (1) have been used to fix the plate to a fragment, subsequent insertion of a cortex screw (2) in the same fragment without loosening and retightening the locking screw is not recommended.

* Found in the Basic Instrument Set, for LC-DCP and DCP

Implantation


CompressionNeutral

8Insert cortex screws in shaft of plate

Insert as many standard 3.5 mm cortex screws as necessary into the distal portion of the plate.

Note: All of the 3.5 mm cortex screws must be inserted prior to insertion of 3.5 mm locking screws.

Use the 3.5 mm Universal Drill Guide (323.360) to predrill for the 3.5 mm cortex screws and drill through both cortices with the 2.5 mm Drill Bit (310.250).

For the neutral position, press the drill guide down in the nonthreaded hole. To obtain compression, place the drill guide at the end of the nonthreaded hole away from the fracture. Do not apply downward pressure on the drill guide’s spring-loaded tip.

Measure for screw length using a depth gauge. Select and insert the appropriate length 3.5 mm cortex screw.


9Insert 3.5 mm locking screws in shaft of plate

Attach the 2.8 mm Threaded Drill Guide (312.648) to a lock-ing hole in the plate shaft. Drill a hole using the 2.8 mm Percutaneous Drill Bit (324.214).

Note: Use of the drill guide is mandatory for screws to lock to the plate properly.

Determine the appropriate screw length indicated on the calibrated drill bit.

Remove the drill bit and drill guide.


Note: Always use the TLA (Torque Limiting Attachment) when using power.

Repeat as necessary to insert additional locking screws.

Examine the limb clinically and radiographically. It is impor-tant that the tibial plateau is in proper orientation to the tibial shaft.

Implantation


75 mm

70 mm

70 mm


Suggested screw lengths to achieve desired screw convergence.

10Insert 3.5 mm locking screws in the oblique holes

Note: Use the oblique locking screws to buttress medial fragments.

Thread a 2.8 mm Threaded Drill Guide (312.648) into the distal oblique locking hole.

Drill with the 2.8 mm Percutaneous Drill Bit (324.214).

Determine the appropriate screw length indicated on the calibrated drill bit.


Repeat steps for the last two oblique locking screws.


Screw length considerationsWhen using the appropriate length screws in the oblique locking holes, the screw tips should meet the proximal lock-ing screws.


Cleaning of Instruments

Cleaning the cannulation in the threaded drill guides is imperative for proper function.

Instruments should be cleared intraoperatively using the 2.5 mm Cleaning Stylet (319.461) to prevent accumulation of debris in the cannulation.

Implant Removal In case the physician decides to remove the implants, they can be removed by using general surgical instruments.

Unlock all screws from the plate, then remove the screws completely from the bone. This prevents simultaneous rotation of the plate when unlocking the last locking screw.For details regarding implant removal refer to the surgical technique “Screw Extraction Set” (DSEM/TRM/0614/0104).


LCP Proximal Tibial Plate 3.5, lateral

Stainless steel Pure Titanium Shaft Length (TiCP) holes (mm)

239.934 439.934 4 81 right

239.936 439.936 6 107 right

239.938 439.938 8 133 right

239.940 439.940 10 159 right

239.942 439.942 12 185 right

239.944 439.944 14 211 right

239.946 439.946 16 237 right

239.935 439.935 4 81 left

239.937 439.937 6 107 left

239.939 439.939 8 133 left

239.941 439.941 10 159 left

239.943 439.943 12 185 left

239.945 439.945 14 211 left

239.947 439.947 16 237 left

LCP Proximal Tibial Plate 3.5, low bend

Stainless steel Pure Titanium Shaft Length (TiCP) holes (mm)

02.124.200 04.124.200 4 76 right

02.124.204 04.124.204 6 102 right

02.124.208 04.124.208 8 128 right

02.124.212 04.124.212 10 154 right

02.124.216 04.124.216 12 180 right

02.124.220 04.124.220 14 206 right

02.124.224 04.124.224 16 232 right

02.124.201 04.124.201 4 76 left

02.124.205 04.124.205 6 102 left

02.124.209 04.124.209 8 128 left

02.124.213 04.124.213 10 154 left

02.124.217 04.124.217 12 180 left

02.124.221 04.124.221 14 206 left

02.124.225 04.124.225 16 232 left

All plates are available sterile packed. For sterile implants add suffix S to article number.

Implants


Screws

Hex Stardrive

X13.010– X12.101– Locking Screw, B 3.5 mm,X13.095 X12.131 self-tapping

X12.367– X12.317– Screw B 3.5 mm withX12.381 X12.331 Conical Head, self-tapping, fully threaded

X12.467– X12.417– Screw B 3.5 mm withX12.481 X12.431 Conical Head, self-tapping, short thread

X04.810– Cortex Screw B 3.5 mm,X04.910 self-tapping

X=2: Stainless steelX=4: Titanium

Implants


Vario Case for LCP Proximal Tibial Plates 3.5

68.120.403 Vario Case for LCP Proximal Tibial Plates 3.5

689.507 Lid (Stainless Steel), size 1/1

68.120.402 Insert for Screws B 3.5 mm

Set for LCP Proximal Tibial Plates 3.5,with Screws B 3.5 mm

Hex Stardrive

Pure Titanium 01.120.407 01.120.417(TiCP)

Stainless steel 01.120.408 01.120.418

Set for LCP Proximal Tibial Low Bend Plates 3.5, with screws B 3.5 mm

Hex Stardrive

Pure Titanium 01.120.480 01.120.482(TiCP)

Stainless steel 01.120.481 01.120.483

Sets


Vario Case for Plate Set LCP Proximal Tibial Plates 3.5

68.120.401 Vario Case for Plate Set LCP-PTP 3.5

689.508 Vario Case Framing, size 1/1, height 45 mm

689.507 Lid (Stainless Steel), size 1/1

01.120.405 Plate Set LCP Proximal Tibial Plates 3.5 (Pure Titanium) in Vario Case

01.120.406 Plate Set LCP Proximal Tibial Plates 3.5 (Stainless Steel) in Vario Case

Additionally required instruments

312.648 LCP Drill Sleeve 3.5, for Drill Bits B 2.8 mm

324.214 Drill Bit B 2.8 mm, with Scale, length 200/100 mm, 3-flute, for Quick Coupling

319.090 Depth Gauge for Long Screws B 3.5 mm, measuring range up to 110 mm

Additionally requiredLCP Small Fragment Instrument Set

Sets


MRI Information

Torque, Displacement and Image Artifacts according to ASTM F 2213-06, ASTM F 2052-06e1 and ASTM F2119-07Non-clinical testing of worst case scenario in a 3 T MRI system did not reveal any relevant torque or displacement of the construct for an experimentally measured local spatial gradient of the magnetic field of 3.69 T/m. The largest image artifact extended approximately 169 mm from the construct when scanned using the Gradient Echo (GE). Testing was conducted on a 3 T MRI system.

Radio-Frequency-(RF-)induced heating according to ASTM F2182-11aNon-clinical electromagnetic and thermal testing of worst case scenario lead to peak temperature rise of 9.5 °C with an average temperature rise of 6.6 °C (1.5 T) and a peak temperature rise of 5.9 °C (3 T) under MRI Conditions using RF Coils (whole body averaged specific absorption rate [SAR] of 2 W/kg for 6 minutes [1.5 T] and for 15 minutes [3 T]).

Precautions: The above mentioned test relies on non-clini-cal testing. The actual temperature rise in the patient will depend on a variety of factors beyond the SAR and time of RF application. Thus, it is recommended to pay particular attention to the following points: – It is recommended to thoroughly monitor patients under-

going MR scanning for perceived temperature and/or pain sensations.

– Patients with impaired thermoregulation or temperature sensation should be excluded from MR scanning proce-dures.

– Generally, it is recommended to use a MR system with low field strength in the presence of conductive implants. The employed specific absorption rate (SAR) should be reduced as far as possible.

– Using the ventilation system may further contribute to reduce temperature increase in the body.

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Synthes GmbHEimattstrasse 34436 OberdorfSwitzerlandTel: +41 61 965 61 11Fax: +41 61 965 66 00www.depuysynthes.com

Not all products are currently available in all markets.

This publication is not intended for distribution in the USA.

All surgical techniques are available as PDF files at www.depuysynthes.com/ifu ©

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Documents

LCP Proximal Tibial Plate 3.5. Part of the Synthes Small ...synthes.vo.llnwd.net/o16/LLNWMB8/INT Mobile/Synthes International... · LCP Proximal Tibial Plate 3.5. Part of the Synthes